The Recall Desk
CriticalFDA (Drugs)·D-0779-2019·Announced 2019-03-20

King Bio Recalls Dr. King's SafeCare Rx Self-Pity Due to Microbial Contamination

King Bio Inc. is recalling 24 bottles of Dr. King's SafeCare Rx Self-Pity due to microbial contamination. The product was distributed in the U.S., Canada, and Australia.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source metadata explicitly identifies the agency classification as 'Class I'. According to the severity rubric, an FDA Class I recall mandates a score of 5 (Critical), as it indicates a reasonable probability that use of the product may cause serious adverse health consequences or death.

Plain-English summary

King Bio Inc. is voluntarily recalling 24 bottles of Dr. King's SafeCare Rx Self-Pity, 2 fl. oz. (59 mL), due to microbial contamination. The product is identified by NDC 57955-2532-2 and UPC 357955253020.

The recall covers specific lots: 031016G (Expiration 03/19) and 081916B (Expiration 08/19). The affected product was distributed nationwide in the United States, as well as in Canada and Australia.

Consumers who have purchased this product should stop using it and contact King Bio Inc. for further instructions or a refund. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.

The recalled product

Product
Dr. King's SafeCare Rx Self-Pity, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955253020, NDC 57955-2532-2
Manufacturer
King Bio Inc.
Category
Drug — Topical / Ophthalmic
Hazard
Affected units
24

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lots: 031016G Exp. 03/19
  • 081916B Exp. 08/19

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 465 recalled by King Bio Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 465 products in this recall →

Related recalls

Same manufacturer · King Bio Inc.

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Same hazard · microbial contamination

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